The subject matter disclosed herein relates generally to radioisotopes used in medical imaging, and more particularly to systems, methods, and an apparatus for preparing the radioisotope to be used in a medical imaging procedure.
In conventional imaging procedures, an individual dose of a premeasured radioisotope or radioisotope is administered to an individual patient. The individual premeasured radioisotope is prepared by a radioisotope supplier (commonly called a radiopharmacy). A cyclotron is used most commonly to prepare the radioisotope. The radioisotope is delivered to a medical facility that administers the individual premeasured radioisotope as a radiopharmaceutical. The individual premeasured radioisotope is prepared by the radioisotope supplier in accordance with a prescription from a physician. The prescription includes a prescribed amount of radioactivity at a future time and a date of the prescribed administration in a known volume of a liquid suitable for injection into a living subject.
The conventional process of radioisotope production in a cyclotron performed by a radioisotope supplier is as follows: The radioisotope supplier irradiates a target material, such as water, in the cyclotron with a beam of protons or deuterons to produce a desired amount of radioactivity in the target material, referred to herein as radioactive water. Typically, the cyclotron is located in a dedicated room. Examples of cyclotron produced radioisotopes include nitrogen-13, fluorine-18, carbon-11 and oxygen-15.
Often, compounds are bond to the radioactive water to produce radioisotopes such as fluorodeoxyglucose (FDG) which is produced using fluorine-18. Other radioisotopes include nitrogen-13 ammonia which is used in myocardial applications, carbon-11 tracers which are commonly used in neurologic applications; and oxygen-15 gas as well as tracers derived from it which are commonly used in blood flow applications. More specifically, the radioactive water is typically delivered to a separate room that includes a synthesizing device for bonding the compound to the radioactive water and a dispensing station for dividing the radioisotope into individual doses that are stored in individual vials or containers.
In general, the room containing the synthesizing device and the dispensing station is designated as a clean room. More specifically, the clean room is maintained to ensure compliance with, for example, International Organization for Standardization 7 (ISO 7) and Good Manufacturing Practice (GMP) guidelines. However, because of the size of the typical clean room, it is often time consuming and expensive to maintain the clean room in accordance with ISO 7 and GMP guidelines. More specifically, it is often time consuming for personnel to maintain the filtering system and cleanliness of the various equipment installed in the clean room in accordance with the ISO 7 as published by the International Organization for Standardization and is incorporated by reference herein and GMP guidelines as published by the Federal Drug Administration (FDA) and are also incorporated herein by reference.